Identity
- Trade Name
- Mehrwegbehältersystem EUDAMED
- Device Name
- Behandlungseinheit Zubehör EUDAMED
- Model / Reference
- 458780 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260586042016 EUDAMED
- Basic UDI-DI
- 426058604SetNG EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The sets consist of several accessories for the suction devices and consist of class 1 medical devices. The sets are necessary for the aspirators to perform their intended use. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: General-purpose suction system, pneumatic
Mehrwegbehältersystem by ASSKEA GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose suction system, pneumatic.
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- VarioAir B BS — Drägerwerk AG & Co. KGaA · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426058604SetNG | Class I | Active |
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Manufacturer
- Manufacturer
- ASSKEA GmbH
- EUDAMED SRN
- DE-PR-000030721
Sources (1)
- EUDAMED 08451359-ce6f-4ad1-ad07-bf66a5838f52 61 fields · synced Jul 8, 2026